Addressing pharmaceutical counterfeiting and compliance with the Falsified Medicines Directive
The World Health Organization (WHO) has estimated that up to 10% of medicines across the globe are counterfeits. It can involve large scale manufacturing and affects every country. Not only does this situation cause a huge profit loss to the pharmaceutical industry, but it also poses dangers to the people taking these counterfeit medicines.
The level of counterfeiting across the pharmaceutical industry is continuing to grow for a multitude of reasons, including the increasingly complex nature of supply chains, the expansion of e-commerce and lack of enforcement capacity. Traceability and supply chain transparency have been longstanding requirements in the automotive and food industries. With a dramatic global increase of counterfeits in industrial and consumer goods, various regulations have been established in order to protect the legal supply chain. While the rate of pharmaceutical counterfeiting is not particularly high in Western countries, we are seeing regulations coming in to help identify, track and trace. The regulatory landscape is dominated by two forthcoming developments: the latest stops on the road to full implementation are the Falsified Medicines Directive (FMD) in Europe and the US FDA’s Unique Device Identification (UDI) system. Both pieces of legislation focus on serialization, now a matter of urgency for suppliers.
Defeating the counterfeiters demands a multilevel approach, an element of which is secure packaging. In Europe, FMD means new harmonized, pan-European measures including obligatory safety features on the outer packaging of the medicines – to carry a unique serial number to identify and authenticate individual products, and to be sealed in a way that visibly enables tamper verification. Not only can this growth in counterfeit medicines be extremely dangerous to patients, but also harmful to the brand owners that manufacture the legitimate product. Clearly, patients are likely to lose confidence in a brand if it is widely counterfeited.
Labels and packaging are helping the pharmaceutical industry meet ever-more complex legislative and compliance requirements for serialization, as governments around the world take to safeguard the health of consumers. In order to ensure optimal security of pharmaceutical packaging, both overt and covert technologies need to be used. A key aspect to the Falsified Medicines Directive is the requirement for tamper verification, which provides a visual indication of whether packaging has been opened or altered since the product was packed and shipped from the manufacturer. Tamper verification can be addressed through a variety of different methods. However, one of the most effective is the use of tamper verification labels, which are popular due to their versatility, to be applied to multiple packaging types and formats, ease of use and ability to carry branded information to the consumer.